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FDA and Duke-Margolis Center for Health Policy announce a 9/18-19 two-day public workshop to discuss pregnancy safety studies.[ Price : $8.95]
Federal Register notice: FDA seeks participation by industry organizations in selecting nonvoting industry representatives to serv...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Institutional Review Board (IRB) Review of Individual Patie...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Clinical Pharmacology Considerations for Peptide Drug Produ...[ Price : $8.95]
Federal Register notice: FDA announces an opportunity to participate in its Chemistry, Manufacturing, and Controls (CMC) Developme...[ Price : $8.95]
FDA grants S4 Medical a de novo authorization to market its esolution esophageal deviation device.[ Price : $8.95]
Novartis recalls one lot of its Sandimmune Oral Solution (cyclosporine oral solution, USP), 100 mg/ml due to crystal formation obs...[ Price : $8.95]
FDA provides further clarification about a safety alert issued earlier this year that recommended against the use of certain surgi...